Four steps medtech startups can’t put off
Developing and commercializing a new medical device is a success worth toasting for medtech startups — but that success also makes it more likely that litigation is in their future.
There are steps medtech startups can take to protect themselves down the road, said Greenberg Traurig shareholder Ginger Pigott, a litigator who defends major medical device manufacturers in court. She also advises medtech startups on early decisions and strategies that could have major ramifications down the road.
Pigott and two other women — Greenberg Traurig lawyer Miki Kolton and Fogarty Innovation Chief Innovation Officer Denise Zarins — will offer their expertise at our DeviceTalks West show in an Oct. 18 panel, “Going the Distance: Building Startups to Last.”
Pigott offered a preview of the panel for Medical Design & Outsourcing readers this week, discussing four steps that medtech startups can’t afford to put off.
1. Understand your path to market
“Sometimes the fastest way to market is not the best. We urge that companies understand not just the regulatory pathways, [but for their] medical device, what classification is it and what are the options to market based on that classification? … A medical device that is premarket approved has legal defenses that most categories of 510(k) devices don’t have. Knowing your options and understanding not only the cost … but understanding what those risks mean helps you not only with your own company and getting the product to market, but also being able to discuss that with investors and having them understand that you’ve made a decision and understand those risks. … The first thing I look at when I get a case about a medical device is how did it get to market? Is it a PMA product, a 510(k), de novo review? Are there any special controls? All of those things immediately tell me whether I have an early motion to dismiss this case because of preemption. It’s the first thing I have to check off the list because it impacts the way I will approach the claim or complaint, and it also impacts hugely the amount of legal spend there will be on the case.”
2. Intellectual property
“Understand and make sure that you have solid advice on how to protect and understand your own intellectual property. This goes in three directions. One is, obviously, protect your intellectual property. The second is other developments that may come along as a result as you continue to do research. And the third is whether you may be potentially infringing on somebody else’s existing rights, so avoiding that waste of time and energy. Most smaller companies spend money in this area already, [but] making sure that you have the right resources to help you understand that is something that cannot be understated.”
3. Define what success looks like
“Ultimately, what’s the goal, what’s the passion, what’s the unmet need? This goes along with the path to market — what ultimately are we looking to do here? Some companies have a goal of being acquired. … The critical thinking that goes along with that is to avoid that tunnel vision. You need to be nimble, in a sense of understanding what the data is telling you. Most companies are constantly getting information and having to adjust. It’s been really illuminating to work with companies when they’re getting information they weren’t necessarily expecting, and then how do they deal with that?”
4. Have a plan before problems pop up
“Before you get bad news, have a plan for how you’re going to discuss things. What kinds of things are discoverable in litigation later? When do you ask a lawyer or consultant for space under attorney-client privilege to talk this through? Not because you want to hide anything — that’s really important — it’s about the fact that communications can be manipulated in hindsight [during litigation]. It’s the same reason why we want doctors that have peer review privilege. We want them to talk about the things that went wrong in an honest and open way. So here, it’s about understanding how to deal with problems if they arise and understanding that things may not always go right. Everybody knows that going in, but they don’t always set up for it. The things that I always emphasize are, ‘How are we communicating? What are we putting in emails? What protocols do we have in place? And are we following them in terms of reporting and understanding adverse events?’ If you’re a company that has clinical trials, it’s really important that you have a lawyer review the clinical trial agreements, the informed consent documents and understand what those actually mean in terms of adverse events coming out of clinical trials and how to communicate with the sites. That can be super important if you’re relying on that data for the development of your product.”